The Importance of Pre-Use Integrity Testing in Sterilizing Filtration - Pharmaceutical Technology

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The Importance of Pre-Use Integrity Testing in Sterilizing Filtration
Pre-use integrity testing of sterilizing-grade filters eliminates the potential adverse effects of filter loading on the integrity-test results, allowing unambiguous correlation with the integrity-test specification established during filter-validation studies.


Pharmaceutical Technology


Russell E. Madsen* is president of the Williamsburg Group, LLC, 18907 Lindenhouse Rd., Gaithersburg, MD 20879, tel. 301.938.4266,
Maik W. Jornitz is group vice-president of global product management, bioprocess of Sartorius Biotech Inc. Theodore H. Meltzer is a consultant for Capitola Consulting Company. Madsen and Meltzer are also members of Pharmaceutical Technology's Editorial Advisory Board.

*To whom all correspondence should be addressed.

Keywords: filtration, integrity testing. sterilization

References

1. F. Hofmann,"Integrity Testing of Microfiltration Membranes." J. Parent. Sci. Tech. 38 (4), 148–159 (1984).

2. J.H. Robertson et al., "PDA Technical Report No. 26: Sterilizing Filtration of Liquids," PDA J. Pharm. Sci. Technol. 52 (S1), (1998).

3. D.B. Pall, "Quality Control of Absolute Bacteria Removal Filters," Bull. Paren. Drug Assoc. 29 (4), 192–204 (1975).

4. A.M. Trotter et al., "Integrity Test Measurements—The Effects of Bacterial Cell Loading," Pharm. Technol. 24 (3), 72–80 (2000).

5. D.C. Grant. and J. G. Zahka, "Sieving Capture of Particles by Microporous Membrane Filters from Clean Liquids," Swiss Contamination Control Quarterly 3 (4a), 160–164 (1990).

6. K.L. Roberts and D.J. Velazquez, "Characterizing the Rating and Performance of Membrane Filters for Liqid Applications Using Latex Spheres," Swiss Contamination Control Quarterly 3 (4a), 71–74 (1990).

7. A.J. Thomas et al., "Detection of L-forms of Pseudomonas aeruginosa during Microbiological Validation of Filters." Pharm. Technol. 14(3), 34–44 (1992).

8. A.M. Trotter et al., "Investigation of a Filter Structure by Microbial Retention Studies: A Synthesis and Elaboration of Prior Findings," PDA J. Pharm. Sci. Technol. 55 (2), 127–133 (2001).


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